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Epidemiological Study to Monitor Study Participants With Resected Stage II (High Risk) or Stage III Colorectal Cancer for Circulating Tumor DNA Before, During and After Their Treatment With Adjuvant Chemotherapy

Trial status:Recruitment Complete
Trial ID:
BNT000-001
NCT ID:
NCT04813627
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Recruitment Complete

Trial Details

This is a multi-site epidemiological study designed to monitor circulating tumor DNA (ctDNA) status in participants with Stage II (high risk)/III colorectal cancer (CRC) following resection/prior to adjuvant chemotherapy (AdCTx), during the course of AdCTx and for a period of up to 630 days (21 months) thereafter, according to CRC stages and disease characteristics.

Participants receive no therapeutic intervention as part of this study. This study will identify participants with confirmed Stage II (high risk)/III CRC that are positive for ctDNA after resection who might be potential candidates for the clinical study BNT122-01 (NCT04486378), a study of RO7198457 after completion of standard adjuvant chemotherapy in this patient population. These participants will have the option to enter screening for BNT122-01 at Screening Visit 2 of that study if they meet the eligibility criteria of BNT000-001 during screening. Data from the assessments from this study (BNT000-001) will be carried across to the BNT122-01 study where feasible.

Medical Condition
  • Colorectal Cancer
  • Trial Drug
  • Regular blood sample collection for ctDNA assessment
  • Phase
    N/A
    Type
    Observational
    Estimated Enrolment
    2200
    Estimated Trial Date
    Jul 2021 - Apr 2025

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No
    Inclusion and Exclusion Criteria
    Inclusion criteria

      Inclusion Criteria:

    • Must have given informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
    • Age ≥ 18 years old at time of signing the informed consent form.
    • Ability to comply with the study protocol, in the investigator's judgment.
    • Must have Stage II/Stage III rectal cancer or Stage II (high risk)/Stage III colon cancer per AJCC 2017 that has been surgically totally resected (R0 confirmed by pathology report). Stage II (high risk) colon cancer is defined as (any of):
      • T4
      • Grade ≥ 3
      • Clinical presentation with bowel obstruction or perforation
      • Histological signs of vascular, lymphatic or perineural invasion
      • \< 12 nodes examined
    • Adequate tumor material in formalin-fixed paraffin embedded blocks or as sectioned tissue (only upon approval by sponsor) must be available, preferably from resection. The specimen should be submitted along with an associated pathology report. Multiple samples may be provided as available, but priority should be given to tissue with the highest tumor content and lowest necrotic area.
    • Intention to receive a standard of care AdCTx within 8 weeks post-surgery, and be scheduled for at least 3 months of treatment (including rest days) according to the treating physician or investigator.
    • Eastern Cooperative Oncology Group Performance Status of 0 or 1.
    • Adequate end-organ function.
    • Exclusion Criteria:

    • Neo-adjuvant (radio)chemotherapy prior to surgery.
    • Prior systemic investigational therapy.
    • Active Hepatitis B virus (HBV) infection.
    • Active hepatitis C virus (HCV) infection.
    • History of human immunodeficiency virus (HIV) antibody positivity.
    • Residual tumor classification following surgery other than R0 (microscopic margin-negative resection).
    • Participants with known past or current malignancy other than inclusion diagnosis, except for:
      • Cervical carcinoma of Stage 1B or less.
      • Non-invasive basal cell or squamous cell skin carcinoma.
      • Non-invasive, superficial bladder cancer.
      • Prostate cancer with a current prostate-specific antigen level \< 0.1 ng/mL.
      • Any curable cancer with a complete response of \> 2 years duration.
    • Participant has not started standard of care AdCTx within 8 weeks post-surgery.
    • Participant has received less than 3 months (including rest days) of AdCTx treatment.
    • Inadequate tumor material (either quality or quantity) to support ctDNA analysis.
    • Participants who have had prior splenectomy.
    • Participants with diagnosed microsatellite instability high tumors.

    Trial Locations

    Location
    Status
    Location
    Ridley-Tree Cancer Center
    California City, California, United States, 93105
    Status
    Location
    John Muir Clinical Research Center
    Concord, California, United States, 94520
    Status
    Location
    Marin Cancer Care
    Greenbrae, California, United States, 94904
    Status
    Location
    The Oncology Institute of Hope
    Los Angeles, California, United States, 90033
    Status
    Location
    Rocky Mountain Cancer Centers - Denver Midtown
    Denver, Colorado, United States, 80218
    Status
    Location
    Cancer Care Specialists Of Central Illinois Sc (Ccsci) - Cancer Care Center Of Decatur
    Decatur, Illinois, United States, 62526
    Status
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